An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49837
• EU PAS number:
  EUPAS49836
• Study ID:
  49837
• Official title and acronym:
  An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Observational Study, Retrospective observational study using electronic health care databases of various types in the Unites States. This study has 2 chronologically consecutive aims: 1) to conduct a feasibility assessment aiming to inform the safety evaluation study and 2) to assess the risk of developing pre-specified and newly identified AESIs following administration of Ad26.COV2.S.
• Study status:
  Ongoing

Research institution and networks

Institutions

Harvard Pilgrim Health Care Institute

HealthCore

Optum

Germany

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Harvard Pilgrim Health Care Institute

Harvard Pilgrim Health Care, Inc. Boston, Massachussets, USA, CVS Health Clinical Trial Services Woonsocket, Rhode Island, USA, HealthCore Wilmington, DE, USA, Humana Louisville, Kentucky, USA

Contact details

Kevin Haynes

Study contact

[e-mail]

Kevin Haynes

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 04/03/2021

Actual: 04/03/2021

Data collection

Planned: 01/04/2021

Actual: 01/04/2021

Date of final study report

Planned: 31/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)